The following data is part of a premarket notification filed by C.b.s. Biotechnics, Inc. with the FDA for Crystalline Bone Screw Endo-osseous.
| Device ID | K834364 |
| 510k Number | K834364 |
| Device Name: | CRYSTALLINE BONE SCREW ENDO-OSSEOUS |
| Classification | Implant, Endosseous, Root-form |
| Applicant | C.B.S. BIOTECHNICS, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | DZE |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-10-27 |
| Decision Date | 1984-03-06 |